T/CAMDI 020-2019 Disposable venous indwelling needle rubber isolation plug

Scope

Main technical content: Disposable venous indwelling needles are used for infusion into the peripheral venous system of the human body. This product has been widely used both domestically and abroad. The indwelling needle isolation plug, which is a rubber component installed in the catheter base of disposable venous indwelling needles to prevent blood leakage, is a major accessory. At present, there are no corresponding national or industry standards in China. With the development of science and technology and the increasing demands for clinical safety, it is necessary to formulate unified standards to meet market supervision requirements. In order to more effectively control the quality of disposable venous indwelling needle rubber isolation plugs and facilitate their use by disposable venous indwelling needle manufacturers, the quality standards for disposable venous indwelling needle rubber isolation plugs were established by referring to the "Disposable Venous Indwelling Needles" (YY 1282-2016), the "Disposable Infusion Sets - Gravity Infusion Type" (GB 8368-2018), the "Biological Evaluation of Medical Devices" (GB/T 16886), the "Methods for Testing Medical Infusion, Transfusion, and Syringe Equipment" (GB/T 14233), and the "Pistons for Disposable Syringes" (YY/T 0243-2016). The drafting of the standards follows the format specified in the "Guidelines for Standardization Work - Part 1: Structure and Writing Rules for Standards" (GB 1.1-2009).

Development Information

Related Standards